Qingdao Bright Moon Biomedical Materials Co Ltd
Registered establishment in Qingdao, Shandong, China. 6 device types, 2 clearances.
Qingdao Bright Moon Biomedical Materials Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Bandage, Elastic, Dressing, Wound, Drug and 4 other device types. Its earliest product listing with the FDA dates from 2014.
6device types registered with the FDA
2510(k) clearances
Registration
| Registered name | QINGDAO BRIGHT MOON BIOMEDICAL MATERIALS CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011210302 |
| FEI number | 3011210302 |
| Establishment type | Manufacturer |
Location
| City | Qingdao |
|---|---|
| Province | Shandong |
| Address | No.788 Mingyue Road,Huangdao |
| Postal code | 266400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | Algitocare alginate bandages/Alginate bandages | 2019 | 280 |
| Dressing, Wound, Drug | Class U | Sterile Silver Alginate Wound Dressing, Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | 2023 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Algitocare hydrogel wound dressing/Hydrogel wound dressing | 2016 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Algitocare alginate wound dressing/ Alginate wound dressing/Calium Alginate Dressing, Algitocare CMC wound dressing/Gelling fiber dressing | 2014 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Algitocare silicone foam dressing/Silicone foam dressing, pimple patches, nose pore strips, Hydrocolloid wound dressing/Algitocare hydrocolloid dressing | 2016 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Algitocare silicone gel sheet/ gel sheet/silicone gel | 2016 | 85 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252167 | 2025-12-19 | FRO | Traditional | This company |
| K220673 | 2023-03-16 | FRO | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Biomedical fibers, Wound dressings, Alginate-based products, Silver alginate dressings |
|---|
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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